K062886 is an FDA 510(k) clearance for the ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on November 6, 2006, 41 days after receiving the submission on September 26, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K062886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2006 |
| Decision Date | November 06, 2006 |
| Days to Decision | 41 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBC — Sealant, Pit And Fissure, And Conditioner |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3765 |